Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV) - Full Text View

Sponsors and Collaborators:	Hamilton Health Sciences Canadian Institutes of Health Research (CIHR)
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00433212

Purpose

The machines and oxygen used to help very premature babies breathe can have side-effects, such as bronchopulmonary dysplasia (BPD). Infants with BPD get more complications (a higher death rate, a longer time in intensive care and on assisted ventilation, more hospital readmissions in the first year of life, and more learning problems) than infants who do not develop BPD. Doctors try to remove the tube in the wind-pipe that links the baby to the breathing machine as soon as possible. However, small babies get tired, and still require help to breathe. One of the standard and common techniques to help them breathe without a tube in the wind-pipe is to use simple pressure support, nasal continuous positive airway pressure or nCPAP. This supports breathing a little, but it is often not enough to prevent the need to go back on the breathing machine.

Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to babies through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy.

The main research question: After being weaned from the breathing machine, is NIPPV better than nCPAP in preventing BPD in premature babies weighing 999 grams or less at birth?

Condition	Intervention	Phase
Respiratory Insufficiency of Prematurity	Device: nCPAP Device: NIPPV	Phase III

MedlinePlus related topics: Premature Babies

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of NIPPV to Increase Survival Without Bronchopulmonary Dysplasia in Extremely Low Birth Weight Infants

Further study details as provided by McMaster University:

Primary Outcome Measures:

Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia [ Time Frame: 36 weeks gestational age ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

All cause mortality at 36 weeks gestational age [ Time Frame: 36 weeks gestational age ] [ Designated as safety issue: Yes ]
All cause mortality before first discharge home [ Time Frame: first discharge home ] [ Designated as safety issue: Yes ]
retinopathy of prematurity [ Time Frame: discharge home ] [ Designated as safety issue: Yes ]
ultrasonographic evidence of brain injury [ Time Frame: 36 weeks gestional age ] [ Designated as safety issue: Yes ]
necrotizing enterocolitis [ Time Frame: 36 weeks gestational age ] [ Designated as safety issue: Yes ]
growth [ Time Frame: discharge home ] [ Designated as safety issue: Yes ]
time to establish full feeds [ Time Frame: discharge home ] [ Designated as safety issue: Yes ]
nosocomial infections [ Time Frame: discharge home ] [ Designated as safety issue: No ]
need for re-intubation [ Time Frame: 36 weeks gestational age ] [ Designated as safety issue: Yes ]
time on supplemental oxygen [ Time Frame: discharge home ] [ Designated as safety issue: No ]
duration of positive pressure respiratory support [ Time Frame: discharge home ] [ Designated as safety issue: Yes ]
comparison of synchronized and non-synchronized NIPPV [ Time Frame: discharge home ] [ Designated as safety issue: No ]
bronchopulmonary dysplasia [ Time Frame: 36 weeks gestational age ] [ Designated as safety issue: Yes ]
air leak syndromes [ Time Frame: 36 weeks gestational age ] [ Designated as safety issue: Yes ]
nasal trauma [ Time Frame: discharge home ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1000
Study Start Date:	April 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Non-invasive respiratory support via nasal intermittent positive pressure ventilation	Device: NIPPV Deliver non-invasive respiratory support via ventilator with NIPPV device
B: Active Comparator Non-invasive respiratory support via nasal Continuous Positive Airway Pressure	Device: nCPAP Deliver non-invasive respiratory support via ventilator with nCPAP device

Detailed Description:

The immature lung of extremely low birth weight (ELBW, < 1000 g) infants is easily damaged by the placement of an endotracheal tube to deliver mechanical ventilation and oxygen. This and the total time of mechanical ventilation contributes to bronchopulmonary dysplasia (BPD). Infants with BPD have an increased risk of later death or neuro-impairment. With the increasing survival of ELBW infants in the NICU, there has been a proportionate increase in the number of infants surviving with BPD.

Following invasive ventilation via an endotracheal tube (ETT), extubation to nasal Continuous Positive Airway Pressure (nCPAP)ventilation is the standard approach. Currently, 40% of infants who are extubated and given nCPAP support fail, and require re-intubation. Previous work suggests that a less invasive respiratory support such as Nasal Intermittent Positive Pressure Ventilation (NIPPV), without an endotracheal tube is less injurious to the lung. NIPPV may thereby reduce the duration of invasive ventilator support, and aid successful early extubation. We hypothesize that the use of NIPPV leads to a higher rate of survival without BPD than standard therapy with nCPAP.

This randomized clinical trial is appropriately powered to compare NIPPV with nCPAP to detect effects on clinically relevant long-term outcomes, such as death and BPD at 36 weeks. This is a multi-national, randomized, open clinical trial of two different standard methods of providing non-invasive respiratory support to 1000 extremely preterm infants weighing less than 1000 grams at birth.

Eligibility

Ages Eligible for Study:	up to 28 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Birth weight <1000 gm
Gestational age <30 completed weeks
Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either:
- the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support;
- the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.

Exclusion Criteria:

Considered non-viable by clinician (decision not to administer effective therapies)
Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
Infants known to require surgical treatment
Abnormalities of the upper and lower airways
Neuromuscular disorders
Infants who are >28 days old and continue to require mechanical ventilation with an endotracheal tube

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433212

Contacts

Contact: Haresh Kirpalani, MD, MSc	905-527-2299 ext 43790	kirpalan@mcmaster.ca
Contact: Brigitte Lemyre, MD	613-737-8561	blemyre@ottawahospital.on.ca

Show 23 Study Locations

Sponsors and Collaborators

Hamilton Health Sciences

Canadian Institutes of Health Research (CIHR)

Investigators

Study Chair:	Haresh Kirpalani, MD, MSc	Hamilton Health Sciences
Study Director:	Brigitte Lemyre, MD	Children's Hospital of Eastern Ontario
Study Director:	Aaron Chiu, MD	St. Boniface General Hospital Research Centre
Study Director:	David Millar, MD	Royal Maternity Hospital, Belfast
Study Director:	Robin S Roberts, MTech	Hamilton Health Sciences/McMaster University
Study Director:	Keith Barrington, MD	Royal Victoria Hospital/McGill University
Study Director:	Bradley Yoder, MD	University of Utah
Study Director:	Peter H Dijk, MD, PhD	University Medical Centrum Groningen

More Information

Responsible Party:	McMaster University ( Haresh Kirpalani/Nominated PI )
Study ID Numbers:	NTG-2007-NIPPV, CIHR MCT-80246, ISRCTN15233270
Study First Received:	February 7, 2007
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00433212
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McMaster University:

prematurity
respiratory insufficiency
non-invasive ventilation
bronchopulmonary dysplasia
hyaline membrane disease

Study placed in the following topic categories:

Bronchopulmonary dysplasia
Body Weight
Birth Weight
Bronchopulmonary Dysplasia
Respiratory Insufficiency
Respiratory distress syndrome, infant

Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Infant, Newborn, Diseases
Infant, Premature, Diseases
Hyaline Membrane Disease

ClinicalTrials.gov processed this record on January 16, 2009